Ibl GmbH: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ibl GmbH” (first 2003, latest 2005), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 95 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CHP | Radioimmunoassay, Estradiol | 1 | 1 |
| CHQ | Chromatographic/Fluorometric Method, Catecholamines | 1 | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 | 1 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 1 | 1 |
| JIT | Calibrator, Secondary | 1 | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 | 1 |
Review panels
- Clinical Chemistry (4)
- Immunology (2)
Most recent Ibl GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K051969 | TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA | CHQ | 2005-10-03 | 75 |
| K041349 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM | CHP | 2004-09-24 | 127 |
| K040923 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA | JLS | 2004-07-22 | 105 |
| K033786 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERONE IN SERUM AND SALIVA | JIT | 2004-02-27 | 85 |
| K032796 | IBL C3D-CIC EIA TEST | CZW | 2004-01-13 | 127 |
| K032254 | IBL C1Q-CIC CIA TEST | DAK | 2003-08-29 | 38 |
Recalls
openFDA lists no recalls under a recalling firm named Ibl GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ibl GmbH?
FDA lists 6 510(k) clearances under the applicant name “Ibl GmbH” (first 2003, latest 2005), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ibl GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ibl GmbH is 95 days.
Which FDA product codes appear under Ibl GmbH?
The most frequent FDA product codes under this applicant name are CHP (Radioimmunoassay, Estradiol, 1); CHQ (Chromatographic/Fluorometric Method, Catecholamines, 1); CZW (Complement C3, Antigen, Antiserum, Control, 1).
Next steps
- See all 6 Ibl GmbH clearances with predicates and recalls
- Run predicate analysis for product code CHP, Ibl GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.